The Absolute Effect / Evidence / SAKK 01/10
Germ Cell Tumours · Radiation Oncology · Stage II Seminoma

SAKK 01/10

Clinical question

Can stage IIA/IIB seminoma be treated with markedly de-escalated carboplatin plus involved-node RT?

Trial context
Population
116 eligible patients with stage IIA or IIB classic seminoma
Intervention
Single-dose carboplatin followed by involved-node RT
Key endpoint
3-year progression-free survival
Time horizon / follow-up
Median follow-up 4.5 years
Absolute Effect

What changes for patients?

A de-escalated regimen of one carboplatin cycle followed by involved-node RT achieved 93.7% 3-year PFS. The prespecified 95% target was not met, so this should be viewed as an investigational de-escalation strategy rather than proof of equivalence to standard RT or cisplatin-based chemotherapy. NNT is not applicable in a single-arm study.

NNT: Not applicable; single-arm phase II

Treatment burden / harm

Grade 3–4 treatment-related toxicity

NNH: Not applicable; single-arm study. Grade 3–4 events included neutropenia 4%, thrombocytopenia 3%, vomiting 1%

Relative effect

Single-arm efficacy: 3-year PFS 93.7%

90% CI 88.5–96.6; target 95% not met

Clinical interpretation

SAKK 01/10 did not meet its prespecified 3-year PFS target for the de-escalated regimen, so the strategy remains investigational rather than equivalent to established stage IIA/IIB seminoma treatment.

Primary publication

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Current-practice context · reviewed 14 October 2026

SAKK 01/10 tested a markedly de-escalated, single-arm strategy for stage IIA/IIB seminoma. Because the prespecified 95% 3-year PFS target was not met, the regimen should remain investigational rather than be treated as equivalent to established radiotherapy or cisplatin-based chemotherapy. Treatment selection should follow current stage-specific guidance and consider long-term second-cancer, cardiovascular, fertility and other late-effect risks.

EAU testicular-cancer guidance ↗ · SAKK 01/10 primary report ↗